Risankizumab for Psoriatic Arthritis

(KEEPsAKE2 Trial)

Recruiting at 197 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Hypersensitivity to risankizumab, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 152

444 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is Risankizumab safe for humans?

Risankizumab has been studied for various conditions, including psoriasis and psoriatic arthritis. It is generally considered safe, but there is an increased risk of infections compared to a placebo. No significant difference in serious adverse events (serious health problems) was found between those taking Risankizumab and those taking a placebo. ^{1 2 3 4 5}

What makes the drug risankizumab unique for treating psoriatic arthritis?

Risankizumab is unique because it targets interleukin-23 (IL-23), a protein involved in inflammation, and is specifically designed for patients who haven't responded well to other treatments. It has shown promising results in improving patient-reported outcomes in clinical trials. ^{3 4 5 6 7}

What data supports the effectiveness of the drug Risankizumab for treating psoriatic arthritis?

Research shows that Risankizumab helps improve patient-reported outcomes in people with psoriatic arthritis, especially those who didn't respond well to other treatments. It works by targeting a specific protein involved in inflammation, which can help reduce symptoms. ^{2 3 5 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults with active psoriatic arthritis, having at least 5 tender and swollen joints, plaque psoriasis or nail changes. It's specifically for those who didn't respond well to or couldn't tolerate previous biologic therapies or conventional treatments.

Inclusion Criteria

I have been diagnosed with psoriatic arthritis for at least 6 months.

I have at least 5 tender and 5 swollen joints.

I have active plaque psoriasis with a plaque larger than 2 cm or nail changes.

Exclusion Criteria

You are allergic to risankizumab.

Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment Period 1

Randomized, double-blind, placebo-controlled period where participants receive either risankizumab or placebo

24 weeks

Visits at Week 0, Week 4, and Week 16

Treatment Period 2

Long-term period where all participants receive open-label risankizumab every 12 weeks

292 weeks

Dosing visits every 12 weeks until Week 316

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

Telephone call 140 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Placebo for Risankizumab
• Risankizumab

Trial Overview The study tests the safety and effectiveness of a drug called Risankizumab against a placebo in treating moderate to severe psoriatic arthritis. Participants are randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

Group I: Risankizumab Experimental Treatment 2 Interventions

Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive blinded placebo followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.

Group II: Placebo Placebo Group 2 Interventions

Participants randomized to receive double-blind placebo at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive 150 mg risankizumab followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

In a 24-week Phase 3 trial involving patients with psoriatic arthritis who had inadequate responses to previous treatments, risankizumab (RZB) significantly improved patient-reported outcomes, including pain, fatigue, and overall health-related quality of life compared to placebo.

Patients treated with RZB reported better scores in multiple health assessments, including the SF-36 and FACIT-Fatigue, indicating enhanced ability to perform daily activities and work, demonstrating its efficacy in managing symptoms of psoriatic arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2. Ostor, AJK., Soliman, AM., Papp, KA., et al.[2022]

Ixekizumab significantly improved disease activity and physical function in patients with active psoriatic arthritis (PsA) compared to placebo, regardless of whether patients were using concomitant conventional disease-modifying antirheumatic drugs (cDMARDs).

While treatment with ixekizumab was associated with a higher frequency of treatment-emergent adverse events compared to placebo, serious adverse events were not more common, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ixekizumab efficacy and safety with and without concomitant conventional disease-modifying antirheumatic drugs (cDMARDs) in biologic DMARD (bDMARD)-naïve patients with active psoriatic arthritis (PsA): results from SPIRIT-P1. Coates, LC., Kishimoto, M., Gottlieb, A., et al.[2022]

Secukinumab demonstrated significant efficacy in treating psoriatic arthritis (PsA), showing robust improvements across all core domains, including joint counts, enthesitis, and skin severity, in a pooled analysis of 2049 patients from multiple phase III studies.

At a dosage of 300 mg, secukinumab led to complete resolution of swollen joints in 34.3% of patients and significant improvements in other symptoms, indicating its potential as an effective treatment option for various manifestations of PsA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Secukinumab on the Different GRAPPA-OMERACT Core Domains in Psoriatic Arthritis: A Pooled Analysis of 2049 Patients. Orbai, AM., McInnes, IB., Coates, LC., et al.[2021]

Risankizumab, a monoclonal antibody targeting IL-23, received its first global approval in March 2019 in Japan for treating various forms of psoriasis, including psoriasis vulgaris and psoriatic arthritis.

The drug is currently approved in multiple regions, including the USA and EU, for moderate-to-severe plaque psoriasis and is undergoing further clinical trials for other conditions like Crohn's disease and ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab: First Global Approval. McKeage, K., Duggan, S.[2020]

Risankizumab-rzaa (Skyrizi®) is an effective treatment for moderate-to-severe psoriasis, as demonstrated in four pivotal Phase III trials involving adult patients, showing both efficacy and safety.

The drug works by targeting interleukin-23p19 (IL-23p19), a key player in the inflammatory process of psoriasis, which helps reduce the symptoms of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Risankizumab-rzaa in the Treatment of Plaque Psoriasis. Reddy, V., Yang, EJ., Myers, B., et al.[2020]

In the phase 3 KEEPsAKE 2 trial involving 444 patients with psoriatic arthritis, risankizumab significantly improved disease outcomes compared to placebo, with 51.3% of patients achieving at least a 20% improvement in their symptoms by week 24.

Risankizumab was well tolerated, with similar rates of serious adverse events (4.0% for risankizumab vs. 5.5% for placebo) and lower rates of serious infections compared to placebo, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Östör, A., Van den Bosch, F., Papp, K., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Ixekizumab efficacy and safety with and without concomitant conventional disease-modifying antirheumatic drugs (cDMARDs) in biologic DMARD (bDMARD)-naïve patients with active psoriatic arthritis (PsA): results from SPIRIT-P1. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Effect of Secukinumab on the Different GRAPPA-OMERACT Core Domains in Psoriatic Arthritis: A Pooled Analysis of 2049 Patients. [2021]

5. England pubmed.ncbi.nlm.nih.gov

The effect of risankizumab on achieving minimal clinically important differences in patient-reported outcomes in patients with psoriatic arthritis: results from KEEPsAKE 1 and 2. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Risankizumab in moderate to severe psoriasis: A systematic review and meta-analysis. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Risankizumab: First Global Approval. [2020]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Risankizumab-rzaa in the Treatment of Plaque Psoriasis. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. [2022]